PLAN-A Data- Bio- and Plan- Bank Collection for SCCA in Denmark

PLAN-A - Data- Bio-and Plan-bank Collection in Patients Treated With Radiotherapy for Squamous Cell Carcinoma of the Anus in Denmark - a DACG Cooperation

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05570279

Acronym

PLAN-A

Enrollment

314

Registered

2022-10-06

Start date

2016-04-01

Completion date

2026-04-01

Last updated

2024-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Cancer

Brief summary

The study is a prospective registration of treatment related-, toxicity-, Quality of life- and outcome data from patients treated in Denmark with radiotherapy for squamous cell carcinoma of the anus (SCCA), as a cooperation within the Danish Anal Cancer Group (DACG). Substudy one: A prospective biobank is collected with the purpose to identify predictive and prognostic markers for outcome. Substudy two: MRI scans are performed to investigate the rate of pelvic insufficience fractures at one year post chemoradiotherapy.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥ 18 * Squamous cell carcinoma of the anus, and indication for curatively intended radiotherapy * Written and oral consent

Exclusion criteria

* Contraindication to blood sampling or MRI scans (substudy 1 and 2) * Other malignant disease within 5 years except from basal cell carcinomas

Design outcomes

Primary

Measure	Time frame	Description
Complete clinical response	3 years	Rate of complete response to primary treatment as defined by clinical and radiological evaluation

Secondary

Measure	Time frame	Description
Early toxicity evaluation by CTCAE	2 weeks after the last day of therapy	The rate of treatment related adverse events (assessed by CTCAE v.4.0) related to bowel, skin, bladder and bone.
Late toxicity evaluation by CTCAE	1 and 3 years post treatment	The rate of treatment related adverse events (assessed by CTCAE v.4.0) related to bowel, skin, bladder and bone.
Quality of life assessed by the EORTC QoL questionaires	2 weeks, 1 and 3 years post therapy	European Organisation for Research and Treatment of Cancer (EORTC) quality of life (QoL) questionnaire (QLQ) C30 (core). The EORTC QLQ-CR29 is a tumor-specific health related QoL questionnaire module for CRC (colorectal cancer) patients, which is designed to complement the EORTC QLQ-C30 questionnaire. Patients are asked to indicate their symptoms during the past week(s). Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.
Prognostic value of ctDNA	At time of treatment completion, an average of 30 days, 1 and 3 years post therapy	Measurement of circulating tumor DNA (in copies per ML)
Incidence of pelvis fractures	1 and 3 years post therapy	Frequency of pelvic insufficience fractures at MRI scans

Countries

Denmark

Outcome results